This study seeks to determine the efficacy of Contrast Enhanced Ultrasound (CEUS) in improving the diagnosis of acute appendicitis in children, when compared to the standard grey-scale ultrasound.
This will be a single-center, non-randomized trial that will add to our institution's current diagnostic algorithm using Contrast Enhanced Ultra Sound (CEUS) in subjects who are clinically suspicious for acute appendicitis. For those who consent to study participation, we propose obtaining a CEUS after the initial gray-scale ultrasound. Once the initial ultrasound is complete, the contrast Lumason® (sulfur hexafluoride lipid type-A microspheres) will be administered through an already existing IV catheter and an abdominal scan will be completed. The patient will then continue with standard of care treatment per his treating physician. The CEUS image will be read at a future time by a Children's Mercy Hospital radiologist blinded to the results of the gray scale ultrasound and computed tomography (CT) scan if one was obtained; these will be used for comparison.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
37
Contrast Enhanced Ultrasound of the appendix
Children's Mercy Kansas City
Kansas City, Missouri, United States
Number of Children With an Accurate Diagnosis of Appendicitis.
Number of children with an accurate diagnosis of appendicitis when compared to the standard grey scale ultrasound and/ or CT scan based on the following categories: Category 1: Normal appendix Category 2: Appendix not fully visualized without secondary signs Category 3: Appendix not fully visualized with secondary signs Category 4: Appendicitis
Time frame: 1 week
Definitive Diagnosis
Proportion of children with definitive diagnosis of appendicitis with use of CEUS.
Time frame: 1 week
Number of Participants Who Required Additional CT Scan
"Number of Participants who Required Additional CT Scan"
Time frame: 30 days
Percentage of Negative Appendectomies
Percentage of negative appendectomies
Time frame: 1 week
Total Cost Difference Compared to Traditional Ultrasound
Costs in comparison to traditional ultrasound
Time frame: 60 days
Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan.
Comparing total costs difference between traditional ultrasound in comparison to costs in CT scan. Total CT Scan Costs - Total Ultrasound Costs = Cost Difference.
Time frame: 60 days
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